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United States Patent |
6,261,318
|
Lee
,   et al.
|
July 17, 2001
|
Expandable stent
Abstract
A stent has a tubular body with longitudinal struts interconnected by
multi-bar linkages. The linkages comprise a pair of circumferential
extending links, a pair of axial links and a pair of spaced hinges located
between the circumferential links and the axial links. The struts inhibit
foreshortening of the body and relative rotation between the links in the
linkages, permitting radial expansion. The links are plastically deformed
as they are expanded to maintain the expanded diameter.
Inventors:
|
Lee; J. Michael (Halifax, CA);
Crewe; Katherine H. (Etobicoke, CA);
Mastrangelo; Christine (Etobicoke, CA)
|
Assignee:
|
Medstent Inc. (Rexdale, CA)
|
Appl. No.:
|
063496 |
Filed:
|
April 20, 1998 |
Foreign Application Priority Data
| Jul 25, 1995[GB] | 9515282 |
| Mar 15, 1996[GB] | 9605486 |
Current U.S. Class: |
623/1.15; 623/1.17; 623/1.3 |
Intern'l Class: |
A61F 002/06 |
Field of Search: |
623/1,12,1.15,1.17,1.2,1.3
606/191,194,195,198
|
References Cited
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|
Foreign Patent Documents |
88 12719 | Oct., 1988 | DE.
| |
0 274 846 | Dec., 1987 | EP.
| |
0 335 341 | Mar., 1989 | EP.
| |
0 540 290 A2 | May., 1993 | EP.
| |
WO 95/03010 | Feb., 1995 | WO.
| |
WO 95/09584 | Apr., 1995 | WO.
| |
WO 96/09013 | Mar., 1996 | WO.
| |
Primary Examiner: Milano; Michael J.
Assistant Examiner: Pellegrino; Brian E.
Attorney, Agent or Firm: Pryor Cashman Sherman and Flynn LLP, Waldbaum, Esq.; Maxim H.
Parent Case Text
This U.S. application is a Continuation in Part of U.S. Ser. No. 08/687,223
filed on Jul. 25, 1996, now issued as U.S. Pat. No. 5,776,181 on Jul. 7,
1998.
Claims
We claim:
1. A stent having a generally tubular body with a plurality of
circumferentially spaced longitudinal struts extending parallel to a
longitudinal axis of said body, circumferentially adjacent pairs of said
struts being interconnected by a plurality of linkages axially spaced from
one another and each including a plurality of links connected to one
another, adjacent links of said linkages being angularly disposed relative
to one another such that a radial force causes relative rotation between
adjacent links and plastic deformation thereof to permit radial expansion
of said stent, said struts being disposed to inhibit relative axial
movement between said linkages and foreshortening of said body; each of
said linkages including a pair of circumferentially extending links and a
pair of axial links connected to one end to respective ones of said
circumferentially extending links, opposite ends of said axial links being
connected to one another by a circumferential link axially spaced from
said circumferentially extending links, said axial links and said
circumferential link being enlarged at their intersection to provide a
pair of spaced hinges between said circumferential links and said axial
links, and external corners of said intersection being radiused.
2. A stent according to claim 1 wherein said axial links are enlarged at
their intersection with said circumferentially extending links and
external corners thereof are radiused.
3. A stent according to claim 1 wherein each of said struts extends between
at least two axially adjacent linkages.
4. A stent according to claim 3 wherein selected ones of said struts are
discontinuous thereby providing a plurality of gaps along the length
thereof, the axial location of said gaps being staggered about the
circumference of said body whereby relative axial movement between said
linkages is inhibited by a strut circumferentially spaced on said body and
axially aligned with said gap, wherein the staggering provides an axial
overlap of adjacent ones of said struts for facilitating flexure of said
stent.
5. A stent according to claim 1 wherein said linkages are unidirectionally
facing with one of said links of said linkage being offset axially from
the connection of said linkage to said struts in a common direction.
6. A stent having a generally tubular body with a plurality of
circumferentially spaced longitudinal struts extending along and parallel
to a longitudinal axis of said body, circumferentially adjacent pairs of
said struts being interconnected by a plurality of linkages axially spaced
from one another and each including a plurality of links connected to one
another, adjacent links of said linkages being angularly disposed relative
to one another such that a radial force causes relative rotation between
adjacent links and plastic deformation thereof to permit radial expansion
of said stent, said struts inhibiting relative axial movement between said
linkages and foreshortening of said body, wherein selected ones of said
struts are discontinuous thereby providing a plurality of gaps along the
length thereof, the axial location of said gaps being staggered about the
circumference of said body whereby relative axial movement between said
linkages is inhibited by struts circumferentially spaced on said body and
axially aligned with said gaps, wherein the staggering provides an axial
overlap of adjacent ones of said struts for facilitating flexure of said
stent.
Description
Expandable stents are widely used to provide local reinforcement in
fluid-carrying vessels within the human body. The stent is essentially a
cylindrical member which may be expanded radially to dilate the vessel and
to provide support for the wall of the vessel to maintain it in the
dilated condition.
In order to insert the stent, it has previously been proposed to place the
stent into the vessel on an expandable or balloon catheter. With the stent
positioned at the appropriate location, the catheter is inflated and the
stent is caused to expand radially against the wall of the vessel. Once
the stent is expanded to the required diameter, the catheter is deflated
and may be removed, leaving the stent in position.
The stent must of course remain expanded against the wall of the vessel and
should be capable of withstanding the forces imposed by the wall of the
vessel. Moreover, the stent should be able to negotiate tight turns in the
arterial system during placement while minimizing damage to the arterial
wall.
A number of different mechanisms have been proposed to permit the expansion
of the stent, including devices which reorient the components forming the
stent so that they may adopt a greater overall diameter.
In another class of stents, as typified by the stent shown in U.S. Pat. No.
4,733,665 to Palmaz, the stent is configured to be plastically deformable
so that after expansion it retains the increased diameter. In the Palmaz
stent, the plastic deformation is provided by means of an open-mesh
diamond structure. As the catheter is expanded, the intersecting members
of the mesh deform so that the stent adopts an increased diameter.
With the arrangements shown in the Palmaz stent and similar configurations,
a radial expansion of the stent is accompanied by an axial foreshortening
of the stent. The degree of foreshortening is predictable but the ultimate
location of the stent along the vessel is not predictable. Thus, one end
of the stent may remain stationary relative to the blood vessel so that
the opposite end is subjected to the maximum axial displacement or there
may be progressive foreshortening from both ends with an intermediate
location remaining stationary. The foreshortening of the stent leads to an
unpredictable location for the stent in its expanded condition and induces
relative movement in an axial direction between the vessel wall and the
stent which is generally undesirable.
It is therefore an object of the present invention to provide a stent in
which the above disadvantages are obviated or mitigated.
In general terms, the present invention provides a stent in which a
plurality of circumferentially-spaced longitudinal struts are
interconnected by multi-bar linkages. Adjacent links of the linkages are
angularly disposed to one another such that a radial force causes relative
rotation between adjacent links to permit radial enlargement of the stent.
The longitudinal struts inhibit foreshortening of the stent so that the
final location of the stent can be predicted.
Embodiments of the invention will now be described by way of example only
with reference to the accompanying drawings, in which
FIG. 1 is a side elevation of an assembled stent;
FIG. 2 is a view on the line 2--2 of FIG. 1;
FIG. 3 is a developed view of the stent shown in FIG. 1;
FIG. 4 is a view on an enlarged scale of a portion of the stent shown in
FIGS. 1-3;
FIG. 5 is a view of the portion of the stent shown in FIG. 4 after radial
expansion;
FIG. 6 is a view similar to FIG. 4 of an alternative embodiment of stent;
FIG. 7 is a view of the embodiment of FIG. 6 after radial expansion;
FIG. 8 is a further alternative of stent shown in FIG. 4;
FIG. 9 is a view of the embodiment of FIG. 8 after radial expansion;
FIG. 10 is a comparative curve between the embodiments of stent shown in
FIGS. 4, 6 and 8;
FIG. 11 is a perspective view of a further embodiment of stent;
FIG. 12 is a developed view of the embodiment of stent shown in FIG. 11;
FIG. 13 is an enlarged view of a portion of the stent shown in FIG. 11;
FIG. 14 is a view similar to FIG. 9 showing the stent after radial
expansion;
FIG. 15 is a sectional view of a stent support and catheter;
FIG. 16 is a developed view, similar to FIG. 12, of a further embodiment;
FIG. 17 is a developed view similar to FIG. 16 of a still further
embodiment;
FIG. 18 is an enlarged view of a portion of the embodiment of FIG. 17; and
FIG. 19 is a developed view similar to FIG. 17 of a yet further embodiment.
Referring therefore to FIG. 1, a stent 10 has a generally tubular body 12
which is initially dimensioned to permit insertion into a vessel such as
an artery.
The body 12 includes a plurality of longitudinal struts 14 which are
interconnected by multi-bar linkages 16. The linkages 16 are regularly
spaced along the axial extent of the struts 14 and maintain struts 14 in
circumferentially spaced relationship.
As can best be seen in FIG. 4, each of the linkages 16 includes a pair of
oppositely directed circumferential links 18 with axial links 20 connected
to the circumferential links 18 and extending parallel to the struts 14
but spaced therefrom. The axial links 20 are connected to an L-shaped
corner link 22 which has an axial leg 24 and circumferential leg 26. The
legs 26 of opposed corner links 22 are interconnected by a circumferential
connecting link 28 to interconnect the adjacent struts 14. The links
18,20,22 and 28 of the linkage 16 are formed by removal of material from a
seamless tube of bio-compatible material so that the links are integrally
connected to one another. Typically such material would be a metal such as
both pure and alloyed titanium, platinum, nitinol memory metals, gold or
stainless steel, and the linkage may suitably be machined through micro
machining techniques. Other materials could be used that are considered
suitable for implantation including plastics materials having the
requisite properties.
Each of the linkages 16 is similar and the relative dimensions between the
links in each linkage determine the change in diameter for a given load.
In a typical example, as shown in FIG. 4, taking the length of the
connecting link 28 to be of unit length, then the relative dimensions of
the other links as indicated by the letters on FIG. 4 are as follows:
a b c d e f g h i j k
1 2 1 0.62 1.125 0.12 2.12 2.0 1.375 1.12 0.12
5 5 5 5 5
The stent 10 is typically inserted into the vessel by using a balloon
catheter 60. The stent 10 is mounted on the catheter 60 shown in FIG. 15.
To assist in placement of the stent 10 on the catheter 60, the stent is
initially located on a support 62 that has a bar-like head 64 and a
tapered body 66. The stent 10 is snugly received on the body 66 which has
a concave recess 68 at one end to locate the tip of catheter 60. A bore 70
extends through the body 66 to accommodate a wire if the catheter is of
the type that employs such.
A protective sleeve 72 is located over the body 66 and is retained on a
boss 74 on the head 64. The sleeve 72 thus protects the stent 10 from
extraneous external forces with the body 66 providing support for the
stent 10 in transit.
To transfer the stent to the catheter 60, the sleeve 72 is removed and the
body 66 is aligned with the catheter 60. The stent may then be slid
axially from the body 66 over the catheter 60 and the support and sleeve
discarded. In this way, the stent is guided during transfer and the
placement of the stent on the catheter facilitated.
The recess 68 assists in locating and aligning the catheter 60 during
transfer and of course the wire, if present, may be fed through the bore
70.
The stent 10 is located on the body 66 such that the links 28 are closer to
the boss 74 than the associated links 18. Transfer of the stent 10 to the
catheter thus ensures that the stent 10 is oriented on the catheter 60
such that the connecting link 28 of the linkage 16 is in advance of the
circumferential links 18 during insertion of the stent 10 into the vessel.
The catheter is inserted into the vessel in a conventional manner until it
is located at the stenosis.
After placement within the vessel, the catheter is then inflated to apply a
radially expanding force to the stent.
As shown in FIG. 5, the application of the radial force causes the
circumferential spacing of struts 14 to increase. The circumferential
links 18 are carried with the struts 14 and a hinging action occurs at the
connection of the axial link 20 to both the circumferential link 18 and
the corner link 22 by plastic deformation of the links. Similarly, the
connecting link 28 hinges at its connection to the corner link 22 to
provide a hinging action between the links. The links 22 is thus bodily
rotated as the struts 14 are spread.
By virtue of the relatively narrow links 20,22, the hinging at their
junction to the larger links 18,22 exceeds the yield point of the material
and causes a permanent deformation and increase in diameter. A pair of
spaced hinge points is thus established and thus the total rotation
required between the axial links 20 and circumferential link 28 is
distributed between two locations.
The catheter is then deflated and removed, leaving the stent 10 in situ. It
will be noted, however, that during inflation the struts 14 maintain the
axial spacing between the circumferential links 18 so that the overall
length of the stent remains the same with no relative axial movement
between the vessel and the stent.
In tests with samples of the configuration of FIGS. 4 and 5, an extension
from the spacing of the struts 14 was increased from an initial value of 6
units to 8.48 units upon application of loads consistent with those used
in the expansion of such stents.
An alternative embodiment of linkage 16 is shown in FIGS. 6 and 7, in which
like components will be denoted with like reference numerals with a suffix
`a` added for clarity.
In the embodiment of FIG. 6, the circumferential link 18a is formed as a
pair of rectangular nodes 30,32 interconnected by a narrow bar 34. The
length of the axial link 20a is reduced to 0.5 of a unit value and a
corresponding reduction in the length of the connecting link 28 to 0.5 is
made. As may be seen in FIG. 7, the application of the radial load causes
the connection at the bar 34 to plastically deform, allowing rotation of
the rectangular bar 32. The connecting link 28a is also subjected to
bending load as well as plastic deformation at the connection to the links
22a.
In tests conducted with samples of the arrangements shown in FIGS. 6 and 7,
the initial spacing of the struts 14 was increased to 8.5 units after
application of a radial force consistent with that found in balloon
catheters.
A further embodiment is seen in FIG. 8 where again like reference numerals
will be used to denote like components with a suffix `b` added for
clarity. In the embodiment of FIG. 8, the connection between the
connecting links 20b and the circumferential links 18b progressively
tapered. In a similar manner, the junction between the connecting link 28b
and the link 22b progressively tapers and in each case the overall length
of the links 20b,28b is reduced from 1 unit value to 0.5 unit value. A
tapering in the order of 45 is found to be appropriate.
The results of tests conducted on the embodiment shown in FIGS. 4, 6 and 8
are represented on the curve of FIG. 10. This curve represents the applied
radial load and the deflection obtained and it will be seen that in each
embodiment there is an initial proportional increase of load and
deflection followed by a much flatter curve indicating a plastic
deformation. Thereafter, the load progressively increases, indicating that
the orientation of the links is approaching a linear orientation. It will
be seen that the embodiment of FIG. 8 provides a lower load to achieve the
requisite deflections. With the provision of the relatively narrow links,
it is possible to control the radial force necessary to expand the stent
and the location at which the bending will occur. The force necessary to
achieve radial expansion must be compatible with the forces available from
a balloon catheter and the reduced width of the links permits this.
Moreover, the plastic deformation of the narrow links maintains control of
the orientation of the wider links during expansion.
A further embodiment is shown in FIGS. 11-14 offering enhanced flexibility
for the stent during insertion, as may be needed to negotiate tight turns
in the arterial system during placement, thereby minimizing damage to the
arterial wall.
In the embodiment of FIGS. 11-14, each of the struts 14c is segmented so as
to be comprised of either a series of unitary struts 40 or a series of
linking struts 42.
The unitary struts 40 alternate with linking struts 42 about the
circumference of stent 10c and in the preferred embodiment an even number
of each is provided so that the linking struts 42 are diametrically
opposed. It is preferred that four linking struts 42 are provided and are
circumferentially spaced at 90.degree. intervals.
Each of the unitary struts 40 extend between two of the linkages 16c so as
to interconnect them. The unitary struts are spaced apart from one another
by a gap indicated at 44 so that each linkage 16c is connected to only one
of the adjacent linkages 16c. By contrast, the linking struts 42 extend
between four of the linkages 16c and are then spaced from the next of the
linking struts 42 by a space indicated at 46.
The space 46 or gap between the unitary struts are circumferentially
aligned to provide annular bands 48 whereas spaces 46 are staggered
between alternate linking struts 42. Each of the linking struts 42 has a
waist 50 to provide a region of enhanced flexibility in a plane tangential
to the surface of the stent 10c. The waist 50 is aligned with one of the
bands 48 and so provides the connection across the band 48 between the
linkages 16c.
As can be seen in FIG. 11, the waists 50 are located at diametrically
opposed locations in the respective band 48 to define a pair of pivot axes
X--X. By virtue of the staggered relationship between adjacent linking
struts 42, the waists 50 are displaced by 90.degree. in adjacent bands 48
so that the pivot axes X--X are disposed at 90.degree..
This arrangement provides flexibility about mutually perpendicular axially
spaced axes allowing relative pivotal movement between sections of the
stent to conform to the vessel into which it is inserted.
The linkage 16c is shown in detail in FIG. 13 and includes circumferential
links 18c and axial links 20c connected by a node 32c.
The circumferential link 28c is connected to axial link 20c by corner link
22c which is formed as a rectangular leg 24c.
It will be noted that the connection of each of the links 18c,20c,28c to
the struts 14c, nodes 32c and corner link 22c by radiused fillets 52 that
reduce local stress concentrations.
In one preferred example, the relative dimensions are as follows:
a b c d e f g h i
1.20 0.75 1.40 1.40 2.00 0.90 0.25 6.9 5.30
The fillets 52 are each 0.125 and the thickness of the material between
0.0625 and 0.125.
With this configuration, the application of a radial load results in the
circumferential expansion shown in FIG. 14 from which it can be seen that
a uniform bending of the links 18c is obtained and that the axial links
20c have assumed a circumferential orientation.
Upon circumferential expansion, the linking struts 42 inhibit
foreshortening as each band 48 has two axial struts that inhibit relative
axial movement between adjacent linkages 16c. At the same time the
relatively flexible waists 50 disposed at 90.degree. to one another
provides the requisite flexibility for insertion of the stent 10c.
Although the embodiment of FIG. 11 shows axes of rotation at 90.degree. to
one another, alternative arrangements may be used by varying the relative
orientation of the waisted links. For example, by spacing the links at
60.degree. angles, three axes of rotation are obtained at axially spaced
locations.
The following relative dimensions of linkage 16 have also been found to
provide satisfactory performance:
EXAMPLE I
a b c d e f g h I
10 7.5 11 17.8 38.6 12.3 3 46 74.2
EXAMPLE II
a b c d e f g h I
10.3 7.7 12.2 17.8 38.6 12.3 3 48.2 74.2
EXAMPLE III
a b c d e f g h i
10.0 7.5 11 14.3 20.4 9.2 3 46 49
In each of these examples, the units are 0.001 inches and the thickness of
the material used was 0.003 inches.
In Examples I and III, the width, ie. circumferential dimension, of the
struts 14 was 5 units and the axial spacing between adjacent linkages 16
was 12 units.
In Example II, the width of the struts 14 was 2.85 units and the axial
spacing between adjacent linkages was 3 units.
In each case, the linkages are repeated 4 times about the circumference.
The diameter of the stent prior to expansion was 65 units and after
expansion with a 45.degree. rotation of the links 20c an outside diameter
of 197 units was obtained with Example II and 152.3 units with Example
III. The axial spacing between linkages 16 was sufficient to permit the
bodily rotation of the corner links as the stent expands radially. The
provision of the strut 14 inhibits foreshortening and therefore ensures
that the linkages can rotate as required.
A further embodiment is shown in FIG. 16 in which like components will be
identified with like reference numerals with a suffix `d` added for
clarity. The embodiment of FIG. 16 is similar to that shown in FIGS. 12
and 13. However, each of the struts 14d is segmented into a series of
unitary struts 40d that extend between two adjacent linkages 16d. The
struts 40d are staggered circumferentially to alternate the direction of
connection between adjacent linkages. The unitary linkages 40d are thus
aligned at diametrically opposed locations and thus define a pair of
orthogonal axes at axially spaced locations to provide flexibility during
insertion.
The stent will of course be dimensioned to fit within the intended vessel
and engage the wall when extended. A typical stent for insertion in an
artery will have a diameter of between 1.5 mm and 3.5 mm when inserted and
may have a diameter of between 2 mm and 12 mm when expanded.
A further embodiment is shown in FIGS. 17 and 18 in which like reference
numerals identify like components with a suffix "e" added for clarity.
The embodiment of FIGS. 17 and 18 has unitary struts 40e distributed at
diametrically opposed locations as shown in FIG. 16.
In the embodiment of FIG. 17 however the struts 40e are increased in width
to approximate the width of the nodes. And, as can be seen in FIG. 18, the
configuration of the links 22e and node 32e is changed. Each of the links
22e is provided with radiused external corners 80 and radiused fillets 82
at the intersection with links 20e and 28e. Similarly, the nodes 32e are
provided with radiused external corners 84 and radiused fillets 86 at the
connection to the links 34e and 20e.
The radiused external corners inhibit interference between adjacent pairs
of links 22e and nodes 32e as the stent 10e is expanded to ensure a
uniform expansion of the inflating balloon. The fillets 82, 86 assist in
stress distribution to effect the proper hinging action of the links.
The relative dimensions of the links may be adjusted to suit the
requirements and in particular to suit the outside diameter of the
balloon. Using the same nomenclature as used in FIG. 13 suitable
dimensions, in inches, for three stents with different internal diameters,
is as follows.
i.d. a b c d e F g h
1 0.0100 0.0060 0.0135 0.0180 0.0190 0.0110 0.0030 0.0515
2 0.0100 0.0060 0.0125 0.0180 0.0195 0.0110 0.0030 0.0505
3 0.0095 0.0060 0.0115 0.0180 0.0195 0.0110 0.0030 0.0485
It will be seen that by varying the spacing between links 20e (dimension
`c`) or the length of link 34 (dimension `a`) the spacing of the struts
40e and hence the circumference may be varied. Appropriate adjustment can
be made to the length of link 20e (dimension `e`) to maintain an expanded
diameter of 4 mm. In each of the above examples, the external corners and
all fillets except those at opposite ends of the links 20 have a radius of
0.002 inches. The fillets at opposite ends of links 20e have a radius of
0.0015 inches.
A further embodiment is shown in FIG. 19 in which like reference numerals
will be used with like components with a suffix "f" added for clarity.
In the embodiment of FIG. 19 each of the linkages 16f is similar to that
shown in FIG. 18. The unitary struts 40f interconnect three linkages 18f
except for the initial strut 40f adjacent one end that interconnects two
linkages 18f.
Circumferentially adjacent struts 40f are staggered relative to one another
so as to provide an axial overlap and a gap 46f. Accordingly,
diametrically opposed connections are established at spaced axial
locations to facilitate flexure of the stent 10f.
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